Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Brainsway.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Brainsway
Information provided by:
Brainsway
ClinicalTrials.gov Identifier:
NCT01361815
First received: May 26, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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Purpose
The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/ Discontinued the Deep TMS Multicenter study for Subjects with Major Depression Disorder (MDD) (Protocol# CTP-0001-00).
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder, Recurrent, Unspecified Major Depressive Disorder, Single Episode, Unspecified |
Other: H-Coil Deep TMS in combination with SSRIs |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI) for Subjects With MDD Who Complete/ Discontinued the CTP-0001-00 Protocol |
Resource links provided by NLM:
Further study details as provided by Brainsway:
Primary Outcome Measures:
- The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Safety:
AE incidence, Vital signs, Physical and neurological examination, Young Manic Rating Scale (YMRS), Suicide Ideation Scale (SSI)
Tolerability:
Number of subjects (%) who discontinue the study, Number of subjects (%) who discontinue the study due to AEs
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| H-Coil Deep TMS Treatment |
Other: H-Coil Deep TMS in combination with SSRIs
The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
Other Name: H-Coil Deep TMS Treatment
|
Eligibility| Ages Eligible for Study: | 22 Years to 68 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatients
- Men and women 22-68 years of age
- Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV).
- Completed the CTP-0001-00 study according to the protocol, i.e., either completed 16 weeks of treatment, or were discontinued from the CTP-0001-00 study protocol after 6 weeks or more from randomization.
- Capable and willing to provide informed consent.
- Able to adhere to the treatment schedule.
Exclusion Criteria:
- Discontinued from CTP-0001-00 study protocol due to the following reasons: Tolerability and safety reason, Non-compliant with the study protocol, Developed documented suicidal ideation as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or suicidal attempt
- Current psychotic disorder
- Sensitivity or allergic or other severe adverse event previously reported for Citalopram, Escitalopram, Fluoxetine, Paroxetine, or Sertraline.
- Known or suspected pregnancy
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
- Minimal MT found for both hands is higher than 75% of stimulator power output.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361815
Locations
| United States, California | |
| University of California (UCLA) | |
| Los Angeles, California, United States, 90095 | |
| UC Davis Center for Mind & Brain | |
| Sacramento and Davis, California, United States, 95817 | |
| Smart Brain and Health | |
| Santa Monica, California, United States, 90403 | |
| United States, Florida | |
| Advanced Mental Health Care Inc. - Juno Beach | |
| Juno Beach, Florida, United States, 33408 | |
| Advanced Mental Health Care Inc. - Royal Palm Beach | |
| Royal Palm Beach, Florida, United States, 33411 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| McLean Hospital - TMS Services | |
| Belmont, Massachusetts, United States, 02478 | |
| United States, New Hampshire | |
| Greater Nashua Mental Health Center | |
| Nashua, New Hampshire, United States, 03060 | |
| United States, New York | |
| Columbia University / New York State Psychiatric Institute | |
| New-York, New York, United States, 10032 | |
| Neuropharmacology Services | |
| New-York, New York, United States, 10021 | |
| United States, North Carolina | |
| Duke Medical Center Department of Psychiatry & Behavioral Sciences | |
| Durham, North Carolina, United States, 27710 | |
| United States, South Carolina | |
| Medical Uni. Of South Carolina (MUSC) | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Senior Adults Specialty Research | |
| Ausitn, Texas, United States, 78757 | |
| UT Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390-8898 | |
| Canada, Ontario | |
| Center for Addiction and Mental Health (CAMH) | |
| Toronto, Ontario, Canada | |
| France | |
| EPS Ville-Evrard | |
| Neuilly Sur Marne, France, 93332 | |
| Germany | |
| Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie | |
| Bonn, Germany | |
| Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität | |
| Munich, Germany | |
| Israel | |
| Beer Yaacov Mental Health Center | |
| Beer Yaacov, Israel | |
| Shalvata Mental Health Center | |
| Hod Hasharon, Israel | |
| Hadasah Ein-Karem Medical Center | |
| Jerusalem, Israel | |
| Kfar Shaul Mental Health Center | |
| Jerusalem, Israel | |
Sponsors and Collaborators
Brainsway
Investigators
| Principal Investigator: | Abraham Zangan, Prof. | Weizmann Institute of Science |
| Principal Investigator: | Yechiel Levkovitz, Prof. | Shalvata Mental Health Center |
More Information
No publications provided
| Responsible Party: | Mr. Shmulik Adler. Director of Regulatory Affairs, Brainsway Ltd. |
| ClinicalTrials.gov Identifier: | NCT01361815 History of Changes |
| Other Study ID Numbers: | CTP-0002-00 |
| Study First Received: | May 26, 2011 |
| Last Updated: | May 26, 2011 |
| Health Authority: | United States: Food and Drug Administration Israel: Ethics Commission Canada: Health Canada Germany: Ethics Commission France: Institutional Ethical Committee |
Keywords provided by Brainsway:
|
Depression MDD SSRIs TMS |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Recurrence Mood Disorders |
Mental Disorders Behavioral Symptoms Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013